MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number	BXA067902A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020 a patient underwent treatment of a thoraco-abdominal aneurysm in the (b)(6) study.A gore® viabahn® vbx balloon expandable endoprosthesis was used in the right renal artery.On (b)(6) 2020 a reintervention took place whereby the right renal artery branch was dilated by balloon angioplasty for occlusion.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10702305
• Report Number: 2017233-2020-01368
• Device Sequence Number: 3933879
• Product Code: PRL
• UDI-Device Identifier: 00733132637492
• UDI-Public: 00733132637492
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: BXA067902A
• Device Catalogue Number: BXA067902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 66